Karl Storz - Endoskope , REF: 27093AA Hopkins Telescope 6... (Karl Storz Endoscopy) – various medical device product ifus c... (2024)

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

Recommended Action

Per FDA guidance

On August 2, 2024, Karl Storz -Endoskope issued a "Urgent: Medical Device Correction" Notification to affected consignees via UPS Ground. Karl Storz asked consignees to take the following actions: 1. Immediately discard any previous revisions of the IFU. 2. Access the updated e-IFU at Karl Storz website 3. Pass on this Urgent Medical Device Correction to all users of the products listed and all other persons who need to be aware within your organization. 4. If you have further distributed the products listed, please identify and promptly notify those recipients of this notice and updated e-IFU. 5. Return the completed Customer Reply Form by Fax or E-Mail to the indicated contact below within 15 calendar days from the date of receipt. 6. Please report any incidents related to this issue to the manufacturer, dealer, or local representative and, if applicable, to the national competent authority, as this is important feedback. 7. (Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.)